Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT01125020|
Recruitment Status : Unknown
Verified May 2010 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : May 18, 2010
Last Update Posted : May 18, 2010
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation Hepatocellular Carcinoma Tumor Recurrence and Metastasis Survival Adjuvant Chemotherapy||Drug: gemcitabine and oxaliplatin Drug: doxorubicin, 5-Fu and cisplatin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||May 2010|
|Estimated Study Completion Date :||December 2010|
|Active Comparator: gemcitabine and oxaliplatin||
Drug: gemcitabine and oxaliplatin
Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.
|Active Comparator: doxorubicin, 5-Fu and cisplatin||
Drug: doxorubicin, 5-Fu and cisplatin
Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times.
- tumor recurrence and metastasis [ Time Frame: within the first year after liver transplantation ]Examination of tumor recurrence include serum levels of alpha-fetoprotein(AFP), chest radiography, abdominal ultrasonography, chest or abdominal computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy
- Postoperative survival [ Time Frame: within the first year after liver transplantation ]Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125020
|Contact: Jun-Yi Wu, MM||0086-021-63240090 ext email@example.com|
|Shanghai First People's Hospital||Recruiting|
|Shanghai, Shanghai, China, 200080|
|Contact: Zhi-Hai Peng, MD 0086-021-63240090 ext 3132 firstname.lastname@example.org|
|Principal Investigator: Jun-Wei Fan, MD|
|Study Chair:||Zhi-Hai Peng, MD||Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine|